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Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT00925626
Recruitment Status : Suspended
First Posted : June 22, 2009
Last Update Posted : June 4, 2015
Sponsor:
Information provided by:
University Hospital, Ghent

Brief Summary:
Randomized, single-blind trial in which one group of patients will be operated with a "Mid-Vastus approach" of the knee joint and the other group will undergo knee surgery with a "Sub-Vastus approach".

Condition or disease Intervention/treatment Phase
Tricompartmental Gonarthrosis Procedure: Sub-Vastus arthrotomy Procedure: Mid - Vastus arthrotomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up
Study Start Date : June 2009
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sub - Vastus arthrotomy
Sub-vastus arthrotomy
Procedure: Sub-Vastus arthrotomy
Sub-vastus arthrotomy
Active Comparator: Mid-Vastus arthrotomy
Mid-vastus arthrotomy
Procedure: Mid - Vastus arthrotomy
Mid-vastus arthrotomy



Primary Outcome Measures :
  1. VAS, KOOS and HSS scales [ Time Frame: at day 1, day 2, day 3, day 4 and day 5 post-operatively ]
  2. Rehabilitation time; time needed for 90° flexion of the knee joint [ Time Frame: post-operatively ]

Secondary Outcome Measures :
  1. VAS, HSS, KOOS questionnaires [ Time Frame: at 6 weeks, 3 months and 12 months after surgery. ]
  2. Amount and type of analgesic drugs used. [ Time Frame: pre-operatively and post-operatively ]


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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients diagnosed with osteoarthrosis of the knee
  • patients must be in good general health condition

Exclusion Criteria:

  • patients with morbid obesity (BMI >45)
  • patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925626


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Peter Verdonk, MD University Hospital, Ghent

Additional Information:
Responsible Party: Peter Verdonk, MD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00925626     History of Changes
Other Study ID Numbers: 2009/256
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases